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Azelastine Side Effects

The most commonly reported side effects of azelastine include treatment failure, fatigue, and headache, based on 28,579 FDA adverse event reports from 2004 to 2025. 7.3% of reports found the drug to be ineffective.

Azelastine side effects

Percentages show how often each reaction appears relative to total reports for azelastine.

1
Drug Ineffective7.3%2,095
2
Treatment Failure6.6%1,890
3
Fatigue6.3%1,805
4
Headache5.3%1,523
5
Nausea5.0%1,433
6
Dyspnoea5.0%1,432
7
Cough4.1%1,162
8
Pain4.0%1,157
9
Diarrhoea4.0%1,141
10
Dizziness3.6%1,040
11
Product Dose Omission Issue3.6%1,037
12
Sinusitis3.6%1,030
13
Asthma3.2%926
14
Off Label Use3.2%905
15
Pneumonia2.9%839

These are voluntary reports and do not establish that azelastine caused these reactions.

Report severity

43.5%Serious12,446 reports
18.1%Hospitalizations5,177 reports
3.1%Fatal875 reports

Seriousness is determined by the reporter, not by OpenClaim.

Azelastine drug interactions

Other drugs that appear in adverse event reports alongside azelastine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dupilumab7.9%2,263
2
Fluticasone6.0%1,706
3
Sodium-oxybate5.5%1,586
4
Ketotifen-fumarate4.8%1,381
5
Olopatadine-hydrochloride4.2%1,192
6
Lenalidomide2.8%787
7
Omalizumab2.5%710
8
Cromolyn-sodium2.1%597
9
Epinastine-hydrochloride2.1%587
10
Treprostinil2.0%576
11
Adalimumab2.0%569
12
Omeprazole1.3%375
13
Esomeprazole1.3%359
14
Etanercept1.2%329
15
Budesonide1.1%312

Taken alongside

1
Fluticasone40.1%11,450
2
Albuterol27.6%7,899
3
Montelukast-sodium22.9%6,552
4
Ergocalciferol20.1%5,745
5
Acetaminophen19.4%5,552
6
Levothyroxine-sodium15.0%4,275
7
Omeprazole14.8%4,227
8
Aspirin14.7%4,211
9
Cetirizine-hydrochloride13.7%3,908
10
Atorvastatin-calcium11.6%3,329
11
Prednisone11.4%3,254
12
Gabapentin11.3%3,234
13
Budesonide11.1%3,174
14
Furosemide9.4%2,695
15
Pantoprazole-sodium9.1%2,612

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports azelastine side effects

62.8% of azelastine adverse event reports involve female patients and 29.4% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female62.8%
Male29.4%
Unknown7.8%

Age group

< 2<0.1%
2–111.3%
12–171.9%
18–6455.7%
65+41.0%

What is azelastine used for

Conditions and purposes for which patients were taking azelastine when the adverse event was reported.

Accidental Exposure To ProductAcute SinusitisAllergic BronchitisAllergic Respiratory DiseaseAllergic Respiratory SymptomAllergic RhinitisAllergic SinusitisAllergyAllergy ProphylaxisAllergy TestAllergy Test PositiveAllergy To AnimalAllergy To ChemicalsAllergy To PlantsAlpha-1 Anti-trypsin Deficiency

Showing 15 of 357 indications

Azelastine brand names and reporting trend

Azelastine is sold under the brand name Astepro.

Brand names

Astepro102

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking azelastine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.